Disposable sanitary speculum for timpanic thermometer probe

ABSTRACT

A sanitary protective cover or sheath for the ear canal probe of a tympanic thermometer. The speculum has a generally tubular body portion and an infrared transparent membrane attached to and sealing the forward end of the body portion. While the tubular body portion is being injection molded of plastic material such a polypropylene or polyethylene, a film of a similar plastic material is mated to the forward end of the membrane and is thus severed from the film and one side thereof thermally bonded to the tubular body portion. At the same time a bonding ring of roughly the same diameter as the forward end of the tubular body portion is injection molded. The ring is thermally bonded to the opposite side of the film in alignment with the forward end of the tubular body portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of Ser. No. 08/459,530, filed Jun. 2, 1995,abandoned, which is a continuation of Ser. No. 08/292,061, filed Aug.17, 1994, abandoned, which is a continuation of Ser. No. 08/182,687,filed Jan. 18, 1994, abandoned, which is a continuation of Ser. No.08/089,402, filed Jul. 8, 1993, abandoned, which is a continuation ofSer. No. 07/668,949, filed Mar. 13, 1991, abandoned, which is acontinuation of Ser. No. 07/045,603, filed Apr. 30, 1987, U.S. Pat. No.5,179,936, which is a continuation-in-part of Ser. No. 06/731,795, filedMay 8, 1985, U.S. Pat. No. 4,662,360, which is a continuation-in-part ofSer. No. 06/663,769, filed Oct. 23, 1984, U.S. Pat. No. 4,602,642.

BACKGROUND OF THE INVENTION

The present invention relates to medical instruments, and moreparticularly, to a disposable cover or sheath for the probe of aclinical thermometer.

The diagnosis and treatment of many body ailments depends upon anaccurate reading of the internal or core temperature of a patient'sbody, and in some instances, upon a comparison to a previous bodytemperature reading. For many years, the most common way of taking apatient's temperature involved the utilization of a Mercury thermometer.This approach has a number of drawbacks. First of all, such thermometersare normally made of glass. They must be inserted and maintained in thepatient's mouth or rectum for several minutes. This is oftendiscomforting to the patient. Furthermore, such thermometers can break,resulting in serious lacerations or Mercury poisoning. In addition,Mercury thermometers are difficult to read, must be sterilized, and mustbe "shaken down" vigorously to place the Mercury at the bottom end priorto use.

Because of the above drawbacks of conventional Mercury thermometers,electronic thermometers were developed and are now in widespread use.Typically, the commercialized versions of such electronic thermometershave been designed for taking a patient's temperature orally orrectally. They have a probe connected by wires to a remote unitcontaining an electronic circuit. The probe is inserted into aprotective, disposable plastic cover or sheath before being insertedinto the patient's mouth or rectum. After the patient's temperature istaken, the sheath is discarded, and the probe is inserted into anothersanitary sheath for taking the next patient's temperature. In thismanner, the electronic thermometer is rapidly reusable withoutcommunicating infectious organisms between patients.

The foregoing type of electronic thermometer typically uses predictivetechniques, by which the patient's temperature reading is taken in asignificantly shorter time period, for example thirty seconds, comparedto the several minutes required for the conventional Mercurythermometers. Such electronic thermometers normally have meters or otherdisplays which enable the operator to determine the temperature muchmore readily than reading the position of the terminal end of a columnof Mercury inside a glass tube. The probe is typically an elongated rodof small diameter. The sheath comprises a hollow tube having an open endand a closed, somewhat pointed end. It has a round cross-section ofrelatively small diameter and is made of a plastic material which is nottoxic.

The tympanic membrane is generally considered by the medical communityto be superior to oral, rectal or auxiliary sites for taking a patient'stemperature. This is because the tympanic membrane is morerepresentative of the body's internal or core temperature and moreresponsive to changes in core temperature. Heretofore, efforts toprovide a method and apparatus for measuring the body temperature viathe external ear canal have not been successful. One approach has beento use a thermister, thermocouple or some other type of device requiringphysical contact with the tympanic membrane. This approach isundesirable because of the discomfort to the patient and the danger ofphysical injury to the tympanic membrane. Another approach has directedair against the tympanic membrane and attempted to measure the increasein temperature in returning air in order to derive the patient'stemperature. Clearly this approach has significant drawbacks in regardto accuracy. A third and better approach to tympanic temperaturemeasurement involves sensing infrared emissions in the external earcanal. In order to accomplish this efficiently, a probe must bepartially inserted into the external ear canal. A cover or sheath mustbe provided for enclosing the frontal portion of the probe to present aclean, sanitary surface to the patient and also to keep the probe freeof ear wax and hair. The probe cover or sheath must be made of materialwhich is substantially transparent to infrared radiation.

As used herein, the term "speculum" shall include any type of cover orsheath adapted to fit over a probe for the purpose just described.Preferably, such a speculum is inexpensive so that it can be disposedafter a temperature reading has been taken and a new speculum installedover the probe for the next patient. This eliminates any need tosterilize such speculums.

U.S. Pat. No. 3,282,106 of Barnes suggests the concept of an infraredthermometer that may be placed in the ear cavity to measure bodytemperature. An infrared detector receives radiation through aninternally polished truncated cone which acts as a shield and which ispartially inserted into the ear canal. This cone is apparently apermanent part of the apparatus and is not removable or disposable. Thespecification of the Barnes patent indicates that this cone was notintended to actually touch any portion of the outer ear. However, Barnesindicates that the cone may lightly touch portions of the outer earbecause of lack of skill of the operator. Nevertheless, no protectivespeculum for the cone is disclosed in Barnes. The aforementioned Barnespatent also discloses an alternate embodiment including a conventionallyshaped ear plug which contacts the external ear canal but is notprovided with a speculum.

U.S. Pat. No. 3,581,570 of Wortz discloses a tympanic temperaturesensing device which has positioning means to establish a fixedrelationship between the eardrum and a radiometer. A polyethylene shieldfits over the probe portion to protect the radiometer. It does notappear that the shield is readily replaceable. Furthermore, the shieldappears to be a cup-shaped member of uniform thickness. The very smallwidth and length of the cup-shaped shield would make it very difficultto handle, install and replace.

U.S. Pat. No. 3,878,836 of Twentier discloses a disposable speculum foran infrared sensing tympanic thermometer. This speculum has the generalshape of a funnel and has open forward and rearward ends. The patentindicates that preferably the speculum is formed of polyethylene. Theprincipal drawback of this speculum is that its open forward end whichis partially inserted into the ear canal may become clogged with wax orother debris and impair proper functioning. Also, the open forward endwill permit germs and other foreign matter to be transferred to thethermometer instrument itself, thus presenting a risk of contaminationand spreading of bacteria and viruses between patients.

A proposed ASTM standard for probe covers for body temperaturethermometers refers to a minimum rupture pressure of 1.2 PSI. Nospecific construction for a probe cover is described in the ASTMstandard.

SUMMARY OF THE INVENTION

Accordingly, it is the primary object of the present invention toprovide an improved, disposable speculum.

It is another object of the present invention to provide a disposablespeculum for the ear canal probe of a tympanic thermometer.

Another object of the present invention is to provide a disposablespeculum configured for easy mounting and removal from the instrumentprobe.

Another object of the present invention is to provide a method offabricating a disposable speculum uniquely suited for an infrared bodytemperature measuring instrument.

Another object of the present invention is to provide a disposablespeculum which acts as a sanitary barrier between a patient's ear canaland the sensing portion of an infrared sensitive tympanic thermometerwhich is partially inserted into the external ear canal after having thespeculum mounted over the same.

The disposable speculum of the present invention comprises a sanitaryprotective cover or sheath for the ear canal probe of a tympanicthermometer. The speculum has a generally tubular body portion and aninfrared transparent membrane attached to and sealing the forward end ofthe body portion. While the tubular body portion is being injectionmolded of plastic material such a polypropylene or polyethylene, a filmof a similar plastic material is mated to the forward end of themembrane and is thus severed from the film and one side thereofthermally bonded to the tubular body portion. At the same time a bondingring of roughly the same diameter as the forward end of the tubular bodyportion is injection molded. The ring is thermally bonded to theopposite side of the film in alignment with the forward end of thetubular body portion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a preferred embodiment of the disposablespeculum of the present invention.

FIG. 2 is an enlarged longitudinal sectional view of the speculum ofFIG. 1.

FIG. 3 is an enlarged longitudinal sectional view illustrating themolding of the speculum of FIG. 1.

FIG. 4 is an enlarged longitudinal sectional view illustrating thespeculum of FIG. 1 mounted over the probe of a tympanic thermometer.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIGS. 1 and 2, the preferred embodiment 10 of ourdisposable speculum includes a generally tubular body portion 12 and aninfrared transparent membrane 14 attached to and sealing the forward endof the tubular body portion. A bonding ring 16 is connected to theperiphery of the membrane 14 and extends forwardly therefrom.

The tubular body portion 12 and bonding ring 16 (FIG. 2) have agenerally frusto-conical or truncated cone configuration. The diameterof the body portion gradually reduces from its rearward end to itsforward end. The ring diameter conforms in shape and size to that of thebody portion. The frusto-conical configuration of the combined bodyportion and ring permits the speculum to be partially inserted into theear canals of both children and adults. The tapered configuration alsoenables the speculum to be snugly fit over and retained on theconformably shaped rigid plastic probe 15 (FIG. 4) of a tympanicthermometer instrument as explained hereafter in greater detail.

Our speculum 10 is preferably made of a non-toxic material since it willcome into contact with a patient's skin. Also, the speculum ispreferably made of a material which is somewhat pliant. This allows thespeculum to deform slightly to facilitate insertion into the ear canaland also to squeeze fit over the instrument probe. Most importantly, themembrane 14 must be made of a material which is substantiallytransparent to infrared radiation, preferably in the seven to fifteenmicron wavelength range, and more preferably substantially transparentto infrared radiation having a wavelength of approximately ten microns.Clinical data has confirmed that accurate internal body temperaturereadings can be made by sensing infrared radiation at the foregoingwavelength which is emitted in the external ear canal.

Polypropylene and polyethylene are both plastic materials which aresubstantially transparent to infrared radiation at the foregoingwavelength. Of course the amount of attenuation of the infraredradiation passing through this material depends upon the thicknessthereof. Accordingly, the membrane 14 must be relatively thin tominimize the attenuation of infrared radiation passing therethrough sothat the thermopile or other detector receiving infrared radiationthrough the membrane will sense the maximum amount of infrared radiationavailable. This enhances the accuracy of temperature measurement. Also,the membrane should have a uniform thickness, with no wrinkles or otherstructural characteristics that will distort the infrared radiationpassing therethrough. Such distortion can introduce errors in thetemperature measurement process.

Accordingly, in the preferred embodiment of our speculum, the membrane14 (FIG. 2) which serves as the IR window is made of polypropylene orpolyethylene film having a maximum thickness of 0.001 inches, andpreferably a thickness in the range of 0.0005 to 0.001 inches.Preferably, the speculum will withstand approximately 1.2 PSI withoutrupturing or otherwise allowing fluid to leak through. As explainedhereafter in greater detail, the membrane 14 is thermally bonded to theforward end of the tubular body portion 12 with the aid of the bondingring 16 in order to ensure it will be able to withstand a minimumapproximately 1.2 internal PSI. The bonding ring has a diametersubstantially equal to that of the forward end of the tubular bodyportion. The ring 16 is bonded to one side of the membrane 14 and theother side of the ring is bonded to the forward end of the tubular bodyportion 12.

The tubular body portion 12 and bonding ring 16 (FIG. 2) of the speculumneed not be made of an infrared transparent material. However, ourspeculum is more easily fabricated and the bond between the membrane andthe body portion is optimized, if the membrane 14, bonding ring 16 andbody portion 12 are made of a similar plastic material. The body portionmust be sufficiently strong such that the speculum can be mounted overthe probe, and removed from the probe, without the operator having totouch the speculum. This ensures that the speculum will be sanitary whenit is introduced into the patient's ear canal. Accordingly, thethickness of the walls of the body portion 12 must be chosen to providesufficient structural integrity to permit the foregoing mounting andremoval from the instrument probe. By way of example, where the bodyportion is made of polypropylene or polyethylene, a wall thickness ofbetween approximately 0.01 to 0.02 inches is adequate.

A rear shoulder 17 (FIG. 1) projects outwardly from the rear end of thetubular body portion. The faces 17a (FIG. 2) of the shoulder can engagea support well (not illustrated) in which the speculum rests. This holdsthe speculum stationary when the probe 15 of the infrared thermometer isinserted into the speculum. A plurality of circumferentially spaced ears18 (FIG. 2) project inwardly from the interior of the tubular bodyportion and mate with corresponding detents 19 (FIG. 4) in thethermometer probe 15 for retaining the speculum on the probe.

By way of example, the outside diameter of the tubular body portion 12may taper from an outside diameter of 0.50 inches immediately forward ofthe shoulder 17 to an outside diameter 0.36 inches at the membrane 14.The tubular body portion 12 in its entirety may have a longitudinaldimension of 0.825 inches.

To facilitate shipment and use, a plurality of the speculums may beconnected in an array of rows and columns by a tree structure (notillustrated) of interconnected rails and side walls made of the sameplastic as the speculum body. This type of structure is illustrated inprior U.S. patent application Ser. No. 731,795 filed May 8, 1985 whichissued as U.S. Pat. No. 4,662,360 on May 5, 1987. Small integrallyformed plastic extensions (not illustrated) may connect the tubular bodyportion of each of the speculums to the rails and side walls of the treestructure. These extensions can be configured and dimensioned to beeasily broken to individually release a selected one of the speculumsupon a predetermined amount of force being applied to the one speculumin a direction away from the tree structure while the tree structure isheld in a stationary position.

The side walls of the aforementioned tree structure may be supported ina housing of a tympanic thermometer as illustrated in U.S. Pat. No.4,602,642. Each speculum may also be seated in a corresponding well inthe housing having walls which engage and support the shoulder faces 17awhen the probe 15 of the thermometer is inserted into the rear end ofthe speculum and pushed downwardly toward the well. The speculum thus issqueezed over the probe and the ears 18 mate with the detents 19 of theprobe 15. As this is done, the extensions break. The probe can then bewithdrawn and the speculum is retained tightly thereon.

Preferably the body portion 12 of the speculum 10 mates with the probe15 so that the membrane 14 is stretched tightly over the probe tip,thereby removing any wrinkles in the membrane. This is illustrated inFIG. 4. When the ears 18 mate with the detents 19 of the probe, themembrane 14 is held in tight, stretched fashion thereby preventing anywrinkles that would interfere with measurement accuracy. The tympanicthermometer has a gold plated wave guide tube 20 (FIG. 4) which extendsconcentrically within, and is spaced from the plastic probe 15. Theouter end of this tube is preferably spaced closely behind the stretchedmembrane 14. The outer end of the tube 20 may be covered with anothersemi-permanent infrared transparent film (not illustrated).

The most convenient way to fabricate the preferred embodiment of ourprobe would be to injection mold the entire speculum in one integralpiece. However, with current plastic molding technology and apparatus,we have found it difficult to integrally mold the entire speculum withthe walls and the membrane having thicknesses in the ranges describedabove.

In order to overcome the foregoing problem, we have discovered that thepreferred method of fabrication is to injection mold the tubular bodyportion and bonding ring 16 and to affix a separate membranetherebetween. A film of a similar plastic material as the tubular bodyportion and ring may be mated to the forward end of the tubular bodyportion and the aft end of the ring while the tubular body portion andring are being injection molded. A portion of the film defining themembrane is thus severed from the film and thermally bonded to thetubular body portion and ring. The strength of the thermal bond isgreatly enhanced if the body portion, film and ring are made of the samematerial. This is because they will then have the same melting point.

The diagrammatic view of FIG. 3 illustrates a preferred method offabricating our speculum. A first mold portion 22 and a second moldportion 24 are mounted for mating engagement. They have cavitiesdefining the shapes of the body portion 12 and bonding ring 16. Moltenplastic is conveyed into these mold cavities through passages 26 and 28in the mold portions. These passages are illustrated in phantom lines.

Molten plastic is injected into the mold cavities after the moldportions 22 and 24 are squeezed together with a web 30 of plastic filmthere between. The film is supported at each end on rollers (notillustrated) coupled to a mechanical drive (not illustrated).

The molten plastic which reaches the film 30 severs a circular portionthereof which becomes the membrane 14. The peripheral edges of thismembrane thermally bond to the frontal end of the molten tubular bodyportion and the rearward end of the bonding ring.

The mold portion 22 is designed with separable parts (not illustrated)so that the body portion 12 may be removed once the mold portions havecooled and the plastic has hardened. The ring 16 and ears 18 are smalland elastic. They can deform sufficiently to allow the now integrallyformed body portions, membrane and ring to be withdrawn from the moldportions. Details of the molding apparatus have not been described asthey will be apparent to those skilled in the plastic molding art.

Having described a preferred embodiment of our speculum and its methodof fabrication, it should be apparent to those skilled in the art thatour invention may be modified in both arrangement and detail. Forexample, the bonding ring 16 may be eliminated if the tubular bodyportion and membrane are otherwise configured to meet the desiredinternal PSI rupture standard. The body portion 12 and ring 16 need nothave a circular configuration. Accordingly, the term "bonding member" asused in the claims shall refer to any auxiliary structure molded on theother side of the membrane in alignment with the forward end of thetubular body portion to aid in securing the membrane to the forward endof the tubular body portion. The term "bonding" as used hereinencompasses not only melting and joining, but other joining techniquessuch as sonic welding and adhesive bonding. Therefore, the protectionafforded our invention should only be limited in accordance with thescope of the following claims.

We claim:
 1. A method of providing a barrier between a patient'sexternal ear canal and an IR sensing probe of a tympanic thermometerwhile permitting infrared radiation emitted in the external ear canal tobe received by the probe, the IR sensing probe having a forward end andthe thermometer containing an IR sensor spaced from the forward end, themethod comprising the steps of:providing a membrane made of astretchable plastic film which is substantially transparent to IRradiation over a predetermined range of wavelengths; providing a bodyportion having an opening sized for having the IR sensing probe insertedtherethrough, the thin film membrane extending across the opening in thebody portion in an unstretched condition; positioning the membraneadjacent the forward end of the probe of the tympanic thermometer;stretching the membrane a predetermined amount across the forward end ofthe probe to remove structural characteristics in the membrane thatwould interfere with measurement accuracy; holding the membranestretched over the forward end of the probe; and partially inserting theforward end of the probe into an external ear canal of a patient withthe membrane stretched over the forward end of the probe; whereby thestretched membrane provides a barrier between the patient's external earcanal and the probe of the tympanic thermometer while permittinginfrared radiation emitted in the external ear canal to be received bythe probe.
 2. A method according to claim 1 wherein the membrane is madeof a material selected from the group consisting of polypropylene andpolyethylene and has an unstretched thickness in the range ofapproximately 0.0005 to 0.001 inches for minimizing attenuation ofinfrared radiation passing therethrough.
 3. A method according to claim1 wherein the body portion includes a plurality of ears that projectinwardly therefrom and the probe includes a plurality of detentstherein, and wherein said step of holding the membrane stretched overthe forward end of the probe further includes mating the ends of thebody portion with the detents of the probe in order to hold the membranestretched over the forward end of the probe.
 4. A method according toclaim 1 and further comprising the steps of removing the membranecovered probe from the external ear canal and disposing the membrane. 5.A method according to claim 1 wherein said step of providing a membranefurther includes attaching the membrane to a forward end of a tubularbody and said step of positioning the membrane adjacent the forward endof the probe further includes mating the body portion with the probe. 6.A method according to claim 3 wherein said step of attaching themembrane to a forward end of the body portion further includes joining afirst side of the membrane to the forward end of the body portion andjoining a bonding ring to a second side of the membrane at a positionopposite the position of attachment of the first side to the bodyportion.